Status:
COMPLETED
A Study of the Effectiveness and Safety of Long-acting Injectable Risperidone Versus Placebo in the Treatment of Patients With Schizophrenia
Lead Sponsor:
Janssen, LP
Conditions:
Schizophrenia
Psychotic Disorders
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to compare the effectiveness and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) versus placebo for the treatment of the symptom...
Detailed Description
Schizophrenia is a severe mental illness that causes changes in a person's perception, thoughts, and behaviour. In schizophrenics, the most common symptoms are positive symptoms (delusions and halluci...
Eligibility Criteria
Inclusion
- Diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV) criteria
- total score at study entry on the PANSS (Positive and Negative Syndrome Scale for Schizophrenia) of \>=60 and \<=120
- patient is otherwise healthy on the basis of a pre-trial physical examination, medical history, electrocardiogram (ECG) findings and results of clinical hematology, biochemistry, and urinalysis tests performed within 1 week of the start of risperidone treatment
- women of child-bearing age must be using an adequate method of birth control and have a negative pregnancy test before the start of risperidone treatment.
Exclusion
- Patients receiving an injectable form of another antipsychotic (last injection within 120 days of screening)
- patients with a DSM-IV Axis I diagnosis other than schizophrenia
- DSM-IV diagnosis of substance dependence within 3 months of start of screening (nicotine and caffeine dependence are allowed)
- history or current symptoms of tardive dyskinesia (a condition seen in patients receiving long-term medication with certain types of antipsychotics in which the patients develop movements of the tongue, lips, face, trunk and hands and feet that they cannot control)
- history of neuroleptic malignant syndrome (a rare condition in patients receiving antipsychotic medication in which a patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state).
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2000
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT00253136
Start Date
November 1 1999
End Date
December 1 2000
Last Update
December 3 2010
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